System and method for managing bluetooth low energy advertising

ABSTRACT

Computer implemented methods and systems are provided that comprise, under control of one or more processors of a medical device, where the one or more processors are configured with specific executable instructions. The methods and systems include sensing circuitry configured to define a sensing channel to collect biological signals, memory configured to store program instructions, a processor configured to implement the program instructions to at least one of analyze the biological signals, manage storage of the biological signals or deliver a therapy, and communication circuitry configured to wirelessly communicate with at least one other implantable or external device, the communication circuitry configured to transition between a sleep state, a partial awake state and a fully awake state. When in the fully awake state, the communication circuitry is configured to execute tasks and actions associated with a communications protocol startup (CPS) instruction set that includes an advertisement scanning related (ASR) instruction subset and a non-ASR instruction subset. When in the partially awake state, the communication circuitry is configured to execute, as the ASR instruction subset, transmit advertising notices over one or more channels according to a wireless communications protocol, scan the one or more channels for a connection request from an external device. When a connection request is not received, return to the sleep state, without performing actions or tasks associated with the non-ASR instruction subset of the CPA instruction set.

BACKGROUND

An implantable medical device (IMD) is a medical device that isconfigured to be implanted within a patient anatomy and commonly employsone or more leads with electrodes that either receive or delivervoltage, current or other electromagnetic pulses from or to an organ ortissue for diagnostic or therapeutic purposes. In general, IMDs includea battery, electronic circuitry, a pulse generator, a transceiver and/ora microprocessor that is configured to handle communication with anexternal instrument as well as control patient therapy. The componentsof the IMD are hermetically sealed within a metal housing.

IMDs are generally programmed by, and exchange data with, externalinstruments controlled by physicians and/or the patient. Somecommercially available external instruments use commercial operatingsystems (e.g., iOS, Android) that communicate through wirelessbi-directional communication links with the IMDs. For example, mobiledevices with Bluetooth Low Energy (BLE) circuitry are available forcommunication with certain implantable medical devices. The bi-directioncommunication links are formed using a wireless communication protocolthat includes advertisement notices received by the externalinstruments. The advertisement notices are broadcast by the IMD atpredetermined constant frequencies. The use of the advertising noticesto facilitate the establishment of wireless communications involves asignificant power consumption for the implanted medical device.

Currently, during an advertising operation, a BLE enabled IMD transmitsadvertise notices and searches for scan requests from external devices.Often the IMD is in a sleep state when it is time to perform anadvertising operation. Thus, the IMD must first wake up from the sleepstate before the IMD is able to transmit an advertisement notice andsearches for a scan request. Each time the IMD awakes from the sleepstate, the IMD performs a predetermined set of startup andinitialization actions or tasks. The IMD utilizes a certain amount ofpower to perform all of the startup and initialization actions/taskassociated with waking up. Over the life of an IMD, the IMD will go tosleep and awake from the sleep state a substantially large number oftimes (e.g., several times each day for several years). Consequently,the actions and tasks that are performed during every wake-up operation,just to perform an advertising operation, utilize an unduly large amountof power over the life of the device.

A need remains for an improved manner to manage the advertisingoperations of an IMD.

BRIEF SUMMARY

In accordance with an embodiment herein, an implantable medical device(IMD) is provided, including sensing circuitry configured to collectbiological signals, memory configured to store program instructions anda processor configured to implement the program instructions to analyzethe biological signals and/or manage storage of the biological signalsor deliver a therapy. The IMD further includes communication circuitryconfigured to wirelessly communicate with at least one other implantableor external device. The communication circuitry may be configured totransition between a sleep state, a partial awake state and a fullyawake state. When in the fully awake state, the communication circuitrymay be configured to execute tasks and actions associated with acommunications protocol startup (CPS) instruction set that includes anadvertisement scanning related (ASR) instruction subset and a non-ASRinstruction subset. When in the partially awake state, the communicationcircuitry may be configured to execute functions, as the ASR instructionsubset. The functions may include to transmit advertising notices overone or more channels according to a wireless communications protocol andto scan the one or more channels for a connection request from anexternal device. When a connection request is not received, thecommunication circuitry may return to the sleep state without performingactions or tasks associated with the non-ASR instruction subset of theCPS instruction set.

In another aspect, a computer implemented method is provided. Undercontrol of one or more processors of a medical device, where the one ormore processors are configured with specific executable instructions,the method may include collecting biological signals, and implementingprogram instructions to analyze the biological signals and/or managestorage of the biological signals and/or deliver a therapy. The methodmay also include communicating wirelessly with at least one otherimplantable or external device and executing tasks and actionsassociated with a communications protocol startup (CPS) instruction setthat includes an advertisement scanning related (ASR) instruction subsetand a non-ASR instruction subset when in the fully awake state. When ina partially awake state, the method may include executing functions, asthe ASR instruction subset. The functions may include transmittingadvertising notices over one or more channels according to a wirelesscommunications protocol, scanning the one or more channels for aconnection request from an external device, and returning to a sleepstate, without performing actions or tasks associated with the non-ASRinstruction subset of the CPS instruction set when a connection requestis not received.

In another aspect, a computer program product is provided. The computerprogram product may include a non-signal computer readable storagemedium with computer executable code to collect biological signals. Thecomputer program product may also include computer executable code toanalyze the biological signals, and/or manage storage of the biologicalsignals, and/or deliver a therapy. The computer program product may alsoinclude computer executable code to communicate wirelessly with at leastone other implantable or external device and execute tasks and actionsassociated with a communications protocol startup (CPS) instruction setthat includes an advertisement scanning related (ASR) instruction subsetand a non-ASR instruction subset when in the fully awake state. When ina partially awake state, the computer executable code may executefunctions, as the ASR instruction subset. The functions may include totransmit advertising notices over one or more channels according to awireless communications protocol, scan the one or more channels for aconnection request from an external device, and return to a sleep statewithout performing actions or tasks associated with the non-ASRinstruction subset of the CPS instruction set when a connection requestis not received.

DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a graphical representation of a heart with animplantable medical device (IMD) implemented in accordance withembodiments herein.

FIG. 1B illustrates a system for integrating external diagnostics withremote monitoring provided by implantable medical devices that managewaking-up the communications circuitry in accordance with embodimentsherein.

FIG. 2 illustrates a block diagram of an IMD formed in accordance withembodiments herein.

FIG. 3A illustrates an example of initialization blocks of a BLEperipheral application in a fully awake state.

FIG. 3B illustrates an example of initialization blocks of a BLEadvertising application in a partially awake state.

FIG. 4 illustrates an example of an application switch sequence betweena BLE advertising application in a partially awake state and a BLEadvertising application in a fully awake state in accordance withembodiments herein.

FIG. 5 is a state machine diagram illustrating states of communicationcircuitry configured in accordance with embodiments herein.

DETAILED DESCRIPTION

The terms “cardiac activity signal”, “cardiac activity signals”, “CAsignal” and “CA signals” (collectively “CA signals”) are usedinterchangeably throughout to refer to an analog or digital electricalsignal recorded by two or more electrodes positioned subcutaneous orcutaneous, where the electrical signals are indicative of cardiacelectrical activity. The cardiac activity may be normal/healthy orabnormal/arrhythmic. Non-limiting examples of CA signals include ECGsignals collected by cutaneous electrodes, and EGM signals collected bysubcutaneous electrodes and/or by electrodes positioned within orproximate to the heart wall and/or chambers of the heart.

The terms “body generated analyte” and “BGA” shall mean a test substanceor specimen that is naturally generated by or naturally present in ahuman body as defined in U.S. Provisional Patent Application 62/875,870,titled “METHODS, DEVICE AND SYSTEMS FOR HOLISTIC INTEGRATED HEALTHCAREPATIENT MANAGEMENT”, filed Jul. 18, 2019, the complete subject matter ofwhich is incorporated herein by reference.

The term “BGA test device” shall mean any and all equipment, devices,disposable products utilized to collect and analyze a BGA as defined inthe '870 provisional application. The BGA test device may implement oneor more of the methods, devices and systems described in the '870provisional application.

The term “biological signal” shall include CA signals, BGA dataindicative of a BGA and the like.

The term “low power” refers to an amount of power that is utilized bythe IMD over a series of predefined actions or tasks that occur uponentry into a partially awake state.

The term “high power” refers to an amount of power that is utilized bythe IMD over a series of predefined actions or tasks that occur uponentry into a fully awake state.

The terms “low power” and “high power” are used in a relational mannerwith respect to one another and are not used to denote specific powerlevels.

FIG. 1A illustrates an implantable medical device (IMD) 101 intended forsubcutaneous implantation at a site near the heart. The IMD 101 includesa pair of spaced-apart sense electrodes 114, 126 positioned with respectto a housing 102. The sense electrodes 114, 126 provide for detection offar field electrogram signals. Numerous configurations of electrodearrangements are possible. For example, the electrode 114 may be locatedon a distal end of the IMD 101, while the electrode 126 is located on aproximal side of the IMD 101. Additionally or alternatively, electrodes126 may be located on opposite sides of the IMD 101, opposite ends orelsewhere. The distal electrode 114 may be formed as part of the housing102, for example, by coating all but a portion of the housing with anonconductive material such that the uncoated portion forms theelectrode 114. In this case, the electrode 126 may be electricallyisolated from the housing 102 electrode by placing it on a componentseparate from the housing 102, such as the header 120. Optionally, theheader 120 may be formed as an integral portion of the housing 102. Theheader 120 includes an antenna 128 and the electrode 126. The antenna128 is configured to wirelessly communicate with an external instrument201 in accordance with one or more predetermined wireless protocols(e.g., Bluetooth, Bluetooth low energy, Wi-Fi, etc.).

The housing 102 includes various other components such as: senseelectronics for receiving signals from the electrodes, a microprocessorfor analyzing the far field CA signals, including assessing the presenceof R-waves in cardiac beats occurring while the IMD is in differentlocations relative to gravitational force, a loop memory for temporarystorage of CA data, a device memory for long-term storage of CA data,sensors for detecting patient activity, including an accelerometer fordetecting acceleration signatures indicative of heart sound, and abattery for powering components.

In at least some embodiments, the IMD 101 is configured to be placedsubcutaneously utilizing a minimally invasive approach. Subcutaneouselectrodes are provided on the housing 102 to simplify the implantprocedure and eliminate a need for a transvenous lead system. Thesensing electrodes may be located on opposite sides of the device anddesigned to provide robust episode detection through consistent contactat a sensor-tissue interface. The IMD 101 may be configured to beactivated by the patient or automatically activated, in connection withrecording subcutaneous ECG signals. The IMD 101 senses far field,subcutaneous CA signals, processes the CA signals to detect arrhythmiasand if an arrhythmia is detected, automatically records the CA signalsin memory for subsequent transmission to an external instrument 201.

As explained herein, the IMD 101 includes electrodes that collectcardiac activity (CA) signals in connection with multiple cardiac beatsand in connection with different IMD locations (e.g., differentpositions and/or different orientations). The IMD 101 also includes oneor more sensors to collect acceleration signatures that are indicativeof heart sounds produced at different points in a cardiac cycle.

FIG. 1B illustrates a system for integrating external diagnostics withremote monitoring provided by implantable medical devices that managewaking-up the communications circuitry in accordance with embodimentsherein. The system may be implemented with various architectures, thatare collectively referred to as a healthcare system 132. By way ofexample, the healthcare system 132 may be implemented as describedherein. The healthcare system 132 is configured to receive data from avariety of external and implantable sources including, but not limitedto, active IMDs 101 capable of delivering therapy to a patient, passiveIMDs or sensors 134, BGA test devices 136, wearable sensors 138, andpoint-of-care (POC) devices 140 (e.g., at home or at a medicalfacility). A POC device 140 may represent one type of BGA test device136. The data from one or more of the external and/or implantablesources is collected and transmitted to one or more secure databaseswithin the healthcare system 132.

For example, the external BGA test device 136 may collect lab testresults for specific tests and then transmit the lab test results to thehealthcare system 132. The BGA test device 136 may be implemented at avariety of physical locations, such as one or more “core” laboratories,a physician's office, ER (emergency room), OR (operating room) and/or amedical facility POC (e.g., during hospitalizations or routinehealthcare visits). The BGA test device 136 may be implemented as anat-home POC device 140 that collects test results periodically orcontinuously monitor one or more body generated analytes (e.g., bloodglucose). The at home POC device may include mobile devices such asiPhone, Android phone, or other mobile device that has Bluetoothwireless network such as Wi-Fi or cellular data capabilities. The athome POC device 140 may transmit the raw BGA data to the medical network(e.g., a local external device and/or remote server). Additionally oralternatively, the at-home POC device 140 may implement a correspondingtest of the BGA data for a characteristic of interest (COI) such as amalnutrition state COI, an electrolyte COI, a cardiac marker COI, ahematology COI, a blood gas COI, a coagulation COI, an endocrinologyCOI. The POC device 140 transmits the COI (and optionally the BGA data)to the healthcare system 120 as the tests are performed at home orelsewhere. The POC device 140 may implement periodic or continuous testsfor glucose levels, such as through sensors and handheld devices offeredunder the trademark FREESTYLE LIBRE® by Abbott Laboratories. Optionally,the BGA test device 136 may be implemented as a fully implantable “labon a chip”, such as an implantable biosensor array, that is configuredto collect lab test results.

Embodiments may be implemented in connection with one or moreimplantable medical devices (IMDs). Non-limiting examples of IMDsinclude one or more of neurostimulator devices, implantable leadlessmonitoring and/or therapy devices, and/or alternative implantablemedical devices. The IMD may represent or include a BGA test device asdescribed in the '870 provisional application. The IMD may represent acardiac monitoring device, pacemaker, cardioverter, cardiac rhythmmanagement device, defibrillator, neurostimulator, leadless monitoringdevice, leadless pacemaker, and the like. For example, the IMD mayinclude one or more structural and/or functional aspects of thedevice(s) described in U.S. Pat. No. 9,333,351 “Neurostimulation MethodAnd System To Treat Apnea” and U.S. Pat. No. 9,044,610 “System AndMethods For Providing A Distributed Virtual Stimulation Cathode For UseWith An Implantable Neurostimulation System”, which are herebyincorporated by reference. Additionally or alternatively, the IMD may bea leadless implantable medical device (LIMD) that include one or morestructural and/or functional aspects of the device(s) described in U.S.Pat. No. 9,216,285 “Leadless Implantable Medical Device Having RemovableAnd Fixed Components” and U.S. Pat. No. 8,831,747 “LeadlessNeurostimulation Device And Method Including The Same”, which are herebyincorporated by reference. Additionally or alternatively, the IMD mayinclude one or more structural and/or functional aspects of thedevice(s) described in U.S. Pat. No. 8,391,980 “Method And System ForIdentifying A Potential Lead Failure In An Implantable Medical Device”and U.S. Pat. No. 9,232,485 “System And Method For SelectivelyCommunicating With An Implantable Medical Device”, which are herebyincorporated by reference. Additionally or alternatively, the IMD may bea subcutaneous IMD that includes one or more structural and/orfunctional aspects of the device(s) described in U.S. application Ser.No. 15/973,195, titled “Subcutaneous Implantation Medical Device WithMultiple Parasternal-Anterior Electrodes” and filed May 7, 2018; U.S.application Ser. No. 15/973,219, titled “Implantable Medical Systems AndMethods Including Pulse Generators And Leads” filed May 7, 2018; U.S.application Ser. No. 15/973,249, titled “Single Site ImplantationMethods For Medical Devices Having Multiple Leads”, filed May 7, 2018,which are hereby incorporated by reference in their entireties. Further,one or more combinations of IMDs may be utilized from the aboveincorporated patents and applications in accordance with embodimentsherein. Additionally or alternatively, the IMD may be a leadless cardiacmonitor (ICM) that includes one or more structural and/or functionalaspects of the device(s) described in U.S. patent application havingDocket No. A15E1059, U.S. patent application Ser. No. 15/084,373, filedMar. 29, 2016, entitled, “METHOD AND SYSTEM TO DISCRIMINATE RHYTHMPATTERNS IN CARDIAC ACTIVITY,” which is expressly incorporated herein byreference.

All references, including publications, patent applications and patents,cited herein are hereby incorporated by reference to the same extent asif each reference were individually and specifically indicated to beincorporated by reference and were set forth in its entirety herein.

FIG. 2 illustrates a block diagram of internal components of the IMD101. The components described herein can include or represent hardwareand software instructions (e.g., software stored on a tangible andnon-transitory computer readable storage medium, such as a computer harddrive, ROM, RAM, or the like) that perform the operations describedherein. The hardware may include electronic circuits that include and/orare connected to one or more logic-based devices, such asmicroprocessors, processors, controllers, or the like. Additionally oralternatively, the components may be hard-wired logic circuits.

The IMD 101 is for illustration purposes only, and it is understood thatthe circuitry could be duplicated, eliminated or disabled in any desiredcombination to provide a device capable of treating the appropriateheart chamber(s) with cardioversion, defibrillation and/or pacingstimulation as well as providing for apnea detection and therapy.Additionally or alternatively, the IMD 101 may be used to generateneurostimulation for application to a desired area of a body, such asspinal cord stimulation, the brain and the like. The housing 102 for theIMD 101, shown schematically in FIG. 2, is often referred to as the“can”, “case” or “case electrode” and may be programmably selected toact as the return electrode for all “unipolar” modes. The housing 102may further be used as a return electrode alone or in combination withone or more of the coil electrodes for shocking purposes. The housing102 further includes a connector (not shown) having a plurality ofterminals. In other embodiments, such as when the IMD represents atransvenous device, the terminals may be configured to be coupled todifferent types of electrodes and leads. All or a portion of theterminals may be used in various combinations. The IMD 101 includes acontroller circuit 160 which controls operation of the IMD 101. Thecontroller circuit 160 may include one or more processors that areconfigured to implement program instructions, stored in memory, to atleast one of analyze the biological signals, manage storage of thebiological signals or deliver a therapy. The controller circuit 160(also referred to herein as a processor module or unit) may include oneor more processors, or equivalent control circuitry, designedspecifically for controlling the monitoring, analysis, storage andtransmission of CA signals, device markers, arrhythmias and the like.

The controller circuit 160 is configured to communicate with various RAMor ROM memory, logic and timing circuitry, state machine circuitry, andI/O circuitry. Typically, the controller circuit 160 includes theability to process or monitor input signals (data) as controlled byprogram code stored in memory. The details of the design and operationof the controller circuit 160 are not critical to this disclosure.Rather, any suitable controller circuit 160 may be used that carries outthe functions described herein. Among other things, the controllercircuit 160 receives, processes, and manages storage of digitizedcardiac data sets from the various sensors and electrodes. For example,while the current IMD 101 as shown may not collect and analyze cardiacdata sets such as IEGM data, additionally or alternatively, the IMD 101may collect, analyze and wireless transmit pressure data, heart sounddata, and the like.

The controller circuit 160 further includes timing control circuitry 179used, among other things, to wake the IMD 101 from a sleep state. Thetiming circuitry 179 may include a clock for synchronizing the timing ofadvertising/connection events and for entering a sleep state between theadvertising/connection events. The clock may determine when the IMD 101should wake up next after processing the advertising/connection eventsbefore going to sleep. The timing circuitry 179 may then set an event towake up in time for the next advertising/connection events.Additionally, the controller circuit 160 may include a startup module210. The processor startup module may include program instructions savedin ROM that, when executed, are utilized to control modules within theIMD 101, such as the memory 194, RF circuit 110, and the like.Alternatively, the startup module 210 may be located on another circuitother than the controller circuit within the IMD 101. The controllercircuit 160 includes an operating system module 215. The operatingsystem module 215 supports the applications that run within the IMD 101.Alternatively, the operating system module 215 may be located on acircuit other than the controller circuit 120. Alternatively, theprotocol stack 220 may be located on another circuit other than thecontroller circuit within the IMD 101. The protocol stack may include acontroller and a host, each containing various communication layers.

A sensing circuit 182 and sensing circuit 184 may also be selectivelycoupled to one or more leads through the switch 174 for collectingsensed physiologic data (e.g., cardiac activity, neural activity,respiratory activity, etc.). The sensing circuits, 182 and 184, mayinclude dedicated sense amplifiers, multiplexed amplifiers or sharedamplifiers. The outputs of the sensing circuits, 182 and 184, areconnected to the controller circuit 160 which, in turn, receives thesensed data and is able to trigger or inhibit the pulse generators, 170and 172, respectively, in a demand fashion in response to the absence orpresence of activity of interest.

Sensed signals are also applied to the inputs of an analog-to-digital(ND) data acquisition system 190. The data acquisition system 190 isconfigured to acquire IEGM signals, neural signals, and the like. Thedata acquisition system 190 converts the raw analog data into a digitalsignal and stores the digital signals in memory 194 for later processingand/or RF transmission to the EI 201. The data acquisition system 190 iscoupled to one or more leads through the switch 174 to sample signalsacross any combination of desired electrodes. The data acquisitionsystem 190 may also be coupled, through switch 174, to one or more ofthe acoustic sensors. The data acquisition system 190 acquires, performsA/D conversion, produces and saves the digital pressure data, and/oracoustic data.

The RF circuit 110 includes communication circuitry, such as an antenna151, a transceiver 153, memory 155, a processor 157 and a collection ofone or more transmit amplifiers and receive amplifiers (showncollectively as amplifiers 159). For example, the processor 157 may besimilar to the microcontroller 160. Optionally, the transceiver 151 maybe provided as a single component or a separate transmitter and aseparate receiver. The one or more transmit amplifiers 159 areconfigured to be selectively connected between an output of thetransmitter of the transceiver 153 and the antenna 151. The one or morereceive amplifiers 159 are configured to be selectively connectedbetween the antenna 151 and an input of the receiver of the transceiver153.

As explained herein, the transmitter and receiver of the transceiver 153exhibit certain power and sensitivity limits based on the components anddesign of a particular implementation, without the addition of transmitor receive amplifiers 159. One or more transmit amplifiers 159 may beprovided to be selectively connected between the output of thetransmitter in the antenna to boost the transmit power, such as up to 10dBm. As another example, the receiver of the transceiver 153 may exhibita receive sensitivity down to −85 dBm when operated alone without theaddition of a separate receive amplifier 159. One or more receiveamplifiers 159 may be provided to be selectively connected between theantenna 151 and the input of the receiver of the transceiver 153 toboost the receive sensitivity, such as down to −100 dBm.

As explained herein, the RF circuit 110 is initialized. The transmitterof the transceiver 153 transmits advertisement notices arranged incomplexes, followed by sleep states in accordance with an advertisementinterval. The receiver of the transceiver 153 performs scan operations,during a receive window, to scan for connection requests. The scanoperation, during an individual receive window, may be performed duringthe same period of time as transmission of the advertisement notices 207over corresponding advertisement channels. Optionally, the receivewindow and scan operation may continue after completion of transmissionof the advertisement notices. Hence, the scan operation and receivewindow may temporarily align with the complex of advertisement noticesand/or extend beyond the complex of advertisement notices 207 into thesleep state of the advertisement interval.

The RF circuit 110 is configured to handle and/or manage thebi-directional communication link between the IMD 101 and the externalinstrument (EI) 201. The RF circuit 110 may include communicationcircuitry configured to transition between a sleep state, a partialawake state, and a fully awake state. For example, when in the fullyawake state, the communication circuitry may be configured to executetasks and actions associated with a communications protocol startup(CPS) instruction set 195 that may include an advertisement scanningrelated (ASR) instruction subset 205 and a non-ASR instruction subset206. The communication circuitry, when in the partially awake state, isconfigured to execute the ASR instruction subset 205. The ASRinstruction subset 205 may include transmitting advertising notices 207over one or more channels according to a wireless communicationsprotocol and scanning the one or more channels for a connection requestfrom an external device. Alternatively, the advertising notices 207 maybe stored in the RF circuit 110. Conversely, when a connection requestis not received, the communication circuitry may return to the sleepstate without performing actions or tasks associated with the non-ASRinstruction subset 206 of the CPS instruction set 195. In the example ofFIG. 2, the CPS instruction set 195 may be stored in memory 194 and/or155, which is accessed by the controller circuit 160 and/or processor157, respectively. The CPS instruction set 195 may provide the wirelessprotocol syntax for the controller circuit 160 and/or processor 157 toassemble data packets, advertisement notices, connection requests,connection responses, establish communication links 104, and/orpartition data received from the EI 201. Additionally or alternatively,the CPS instruction set 195 may be stored in ROM, RAM, firmware or othermemory on the RF circuit 110. As a further example, the CPS instructionset 195 may be “stored” through settings of hardware circuitry withinthe RF circuit 110.

In an embodiment, the communication circuitry of the RF circuit 110,when executing the CPS instruction set 195 with the BLE peripheralapplication in the fully awake state, may utilize a first amount ofpower. Also, when executing the ASR instruction subset 205 with the BLEperipheral application in the partially awake state, the CPS instructionset 195 may utilize a second amount of power that is less than the firstamount of power. The CPS instruction set 195 may include more task andactions that take a longer period of time and more power to implementversus the task and actions of the ASR instruction subset 205. Forexample, the second amount of power, to implement the ASR instructionsubset, may be between 40%-80% of the first amount of power to implementthe entire CPS instruction set. As another example, the second amount ofpower, to implement the ASR instruction subset, may be between 50%-65%of the first amount of power to implement the entire CPS instructionset.

The RF circuit 110 includes a receiver that scans for connectionrequests from the EI 201. The RF circuit 110 is controlled by thecontroller circuit 160 and may support one or more wirelesscommunication protocols while communicating with the EI 201, such asBluetooth low energy, Bluetooth, Medical Implant Communication Service(MICS), and/or the like. The RF circuit 110 may include a transmitter,receiver, and/or a transceiver. Optionally, the RF circuit 110 may beelectrically coupled to an antenna (not shown).

The controller circuit 160 is coupled to the memory 194 by a suitabledata/address bus 196, wherein the programmable operating parameters usedby the controller circuit 160 are stored and modified, as required, inorder to customize the operation of IMD 101 to suit the needs of aparticular patient. The memory 194 also stores data sets (raw data,summary data, histograms, etc.), such as the IEGM data, heart sounddata, pressure data, Sv02 data and the like for a desired period of time(e.g., 1 hour, 24 hours, 1 month). The memory 194 may store instructionsto direct the controller circuit 160 to analyze the cardiac signals andheart sounds identify characteristics of interest and derive values forpredetermined statistical parameters.

In addition, the memory 194 stores CPS instruction set 195. The CPSinstruction set 195 may be loaded in the memory 194 at the time ofmanufacture, at the time of activation, at the time of installation orthroughout operation. The CPS instruction set 195 includes the ASRinstruction subset 205 and non-ASR instruction subset 206. The ASRinstruction subset 205 may include at least two of the following: i)expiration of a wake-up timer, ii) processor startup, iii)initialization of a transmit circuit, iv) transmission of advertisingdata packets, v) scanning one or more channels for a connection requestfrom an external device, or vi) validating or denying an incomingconnection request. The non-ASR instruction subset 206 may include atleast two of the following: i) initialization of a random-access memory(RAM) segment/block, ii) initialization of an external instrumentcomponent, iii) initialization of an operating system service, or iv)initialization of the CPS instruction set 195. In one embodiment, theASR instruction subset 205 does not include at least two of thefollowing: i) initialization of a random-access memory (RAM)segment/block, ii) initialization of an external instrument component,iii) initialization of an operating system service, or iv)initialization of the CPS instruction set 195. In another embodiment,the ASR instruction subset 205 does not include any of the following: i)initialization of a random-access memory (RAM) segment/block, ii)initialization of an external instrument component, iii) initializationof an operating system service, or iv) initialization of the CPSinstruction set 195.

In accordance with embodiments herein, advertisement schedules includedin the CPS instruction set 195 balance fast advertisement at low powerand low sensitivity in conjunction with slow advertisement at high powerand high sensitivity, to afford quick patient initiated communicationsand to afford longer range automatic connections for remote monitoring.As explained herein, once a connection is made between the externalinstrument and the IMD, the RF circuit 110 may set the transmit powerand receive sensitivity to a desired communications session level (e.g.,high) for a duration of the communication session. The transmit powerand receive sensitivity are set to the desired communications sessionlevel regardless of whether the connection was established using shortor long range advertisement, thereby affording a desired communicationsdistance during an active communications session. For example, if apatient wanted to initiate a remote monitoring session, the patientwould hold the external instrument (smart phone) close to the body inorder to begin the communications session in accordance with short rangeadvertisement. Then once the connection is made, the RF circuit 110adjusts the transmit power and receive sensitivity to a communicationssession level (e.g., max power settings), thereby allowing the patientto leave the external instrument (smart phone) on a table and go to bedon the other side of the room without experiencing any disruption of thecommunication session.

Additionally or alternatively, one or more separate advertisementschedules included in the CPS instruction set 195 may be stored in thememory 194 to be used in connection with individual corresponding EIs201. For example, when an IMD 101 initially begins communicating with aparticular EI 201, the EI 201 may download a corresponding advertisementschedule included in the CPS instruction set 195, along with theinstruction to utilize the advertisement schedule included in the CPSinstruction set 195 until otherwise instructed. Subsequently, the IMD101 may communicate with another EI 201 that downloads a correspondingnew advertisement schedule included in the CPS instruction set 195,along with an instruction to utilize the new advertisement scheduleincluded in the CPS instruction set 195 until otherwise instructed. As afurther example, the IMD 101 may update the advertisement scheduleincluded in the CPS instruction set 195 throughout operation, such asbased upon the success rate at which communications links areestablished, based on delays when establishing communications links andthe like.

The operating parameters of the IMD 101 may be non-invasively programmedinto the memory 194 through the RF circuit 110 in bi-directionalwireless communication with the EI 201. The RF circuit 110 is controlledby the controller circuit 160 and receives data for transmission over acontrol line 111. The RF circuit 110 allows intra-cardiac electrograms,pressure data, acoustic data, Sv02 data, and status information relatingto the operation of IMD 101 (as contained in the controller circuit 160or memory 194) to be sent to the EI 201 through an establishedbi-directional communication link 104. The RF circuit 110 also allowsthe EI 201 to program new parameters and advertisement schedules for theIMD 101.

The RF circuit 110 transmits one or more advertisement notices on one ormore advertisement channels. Each advertisement channel is a point tomultipoint, unidirectional, channel to carry a repeating pattern ofsystem information messages such as network identification, allowable RFchannels to establish the communication link 104, and/or the like thatis included within the advertisement notice. The advertisement noticemay be repeatedly transmitted after a set duration or an advertisementinterval based on an advertisement schedule stored in the memory 194until the communication link 104 is established with the EI 201.

The IMD 101 may also include a physiologic sensor 112, such as anaccelerometer commonly referred to as a “rate-responsive” sensor becauseit is typically used to record the activity level of the patientaccording to the exercise state of the patient. Optionally, thephysiological sensor 112 may further be used to detect changes incardiac output, changes in the physiological condition of the heart, orchanges in activity (e.g., detecting sleep and wake states) and movementpositions of the patient. While shown as being included within IMD 101,it is to be understood that the physiologic sensor 112 may also beexternal to the IMD 101, yet still be implanted within or carried by thepatient. A common type of rate responsive sensor is an activity sensorincorporating an accelerometer or a piezoelectric crystal, which ismounted within the housing 102 of the IMD 101. Other types ofphysiologic sensors are also known, for example, sensors that sense theoxygen content of blood, respiration rate and/or minute ventilation, pHof blood, ventricular gradient, etc. However, any sensor may be usedwhich is capable of sensing a physiological parameter that correspondsto the exercise state of the patient and, in particular, is capable ofdetecting arousal from sleep or other movement.

The IMD 101 additionally includes a battery 113, which providesoperating power to all of the circuits shown. Optionally, the IMD 101may include an impedance measuring circuit 115 which is enabled by thecontroller circuit 160 via a control signal 214. Herein, impedance isprimarily detected for use in evaluating ventricular end diastolicvolume (EDV) but is also used to track respiration cycles. Other usesfor an impedance measuring circuit include, but are not limited to, leadimpedance surveillance during the acute and chronic phases for properlead positioning or dislodgement; detecting operable electrodes andautomatically switching to an operable pair if dislodgement occurs;measuring respiration or minute ventilation; measuring thoracicimpedance for determining shock thresholds; detecting when the devicehas been implanted; measuring stroke volume; and detecting the openingof heart valves, etc. The impedance measuring circuit 115 isadvantageously coupled to the switch 174 so that impedance at anydesired electrode may be will soon as the obtained.

BLE Peripheral Application in a Fully Awake State and a Partially AwakeState

FIG. 3A illustrates an example set of initialization operations/blocksperformed by a BLE peripheral application upon entering in a fully awakestate. The illustrated process represents a non-limiting example of aset of initialization actions or tasks for a BLE peripheral applicationoperating while communication circuitry of an RF circuit 110 is in afully awake state.

At 310, the wakeup timer expires and the BLE peripheral application isactivated. For example, the IMD 101 may wake up from a predeterminedsleep interval. This interval may occur in betweenconnection/advertising events. These connection/advertising events maybe controlled by the timing control circuitry 179 as shown in the blockdiagram in FIG. 2. The timing control circuitry 179 may include a sleepclock. When the wakeup timer expires at the end of the sleep interval,the timing control circuitry 179 may process the currentconnection/advertising event and establish a new sleep interval usingthe sleep clock.

At 315, a processor startup routine commences. For example, the startupmodule 210 may be utilized to control a boot process of the processor.For example, after the timing control circuitry 179 has determined awakeup interval for the IMD 101, the startup module 210 may include ROMor non-volatile Flash memory with boot code utilized to control the bootprocess. The ROM may load the boot process. The boot process may includepower on, operating system load, and transfer of control to theoperating system. For example, subsequent to a power on activityinitiated by a user, condition, timer, or other stimulus, a routine maybe executed to ensure that the device drivers are functioning properly.Any issues encountered may halt the boot process. Each device in a bootlist may load its own routine to ensure proper communication between thedevices and the startup module 210. After a successfully completedroutine, the operating system 215 may be loaded.

At 320, the RF circuit is initialized. The RF circuit 110 is controlledby the controller circuit 160 and may support one or more wirelesscommunication protocols while communicating with the EI 201, such asBLE, Bluetooth, MICS, and/or the like. The RF circuit 110 may include atransmitter, receiver, and/or a transceiver. The RF circuit 110transmits one or more advertisement notices on one or more advertisementchannels. Each advertisement channel is a point to multipoint,unidirectional, channel to carry a repeating pattern of systeminformation messages such as network identification, allowable RFchannels to establish the communication link 104, and/or the like thatis included within the advertisement notice. The advertisement noticemay be repeatedly transmitted after a set duration or an advertisementinterval based on an advertisement schedule stored in the memory 194until the communication link 104 is established with the EI 201.

At 325, the memory 194 is initialized. For example, operating parametersmay be loaded into certain memory locations and/or registers. The memory194 may store the programmable operating parameters used by thecontroller circuit 160. The memory 194 also stores data sets, such asthe IEGM data, heart sound data, pressure data, Sv02 data and the likefor a desired period of time. The memory 194 may also store instructionsto direct the controller circuit 160 to analyze the cardiac signals andheart sounds identify characteristics of interest and derive values forpredetermined statistical parameters. Additionally, the memory 194stores one or more advertisement schedules included in the CPSinstruction set 195.

At 330, external instrument initialization is performed. For example,the application on an external instrument, such as a programming ormobile device, is activated by a user for an interactive session or by apre-scheduled wake up timer for background communications to the IMD foran IMD status check. Once the communication session is started by eithermeans, the EI 201 sends a connection request. The connection request mayinclude a unique ID for the external instrument. The unique ID may beloaded into a register of the RF circuit 110 during the initializationat 330.

At 335, operating system services are initialized. After a successfulcompleted BIOS, the operating system 215 may commence to runapplications. The operating system 215 may comprise various applicationprograms for collecting and analyzing biological signals.

At 340, the BLE protocol stack 220 is initialized. The protocol stack220 may include a host and controller comprising multiple layersutilized for communication.

At 345, the BLE peripheral application transmits one or more advertisingnotices. The protocol stack 220 controls the time at which theadvertising notice(s) are sent. The Link Layer (LL) of the controller ofthe protocol stack 220 controls the radiofrequency (RF) state of thedevice, which includes the advertising state. It should be noted thatthe scan request and scan response activities occur during theadvertising intervals of both applications.

At 355, the BLE peripheral application determines whether a connectionrequest has been received. If there are no connection requests, theprocess ends for both applications and the IMD goes back to sleep asillustrated at 360. Alternatively, if a connection request is received,the process proceeds to 350.

At 350, the BLE peripheral application analyzes the content of theconnection request, such as to determine if the connection request wassent by an authorized EI 201. If the connection request is sent by anauthorized EI 201, the IMD 101 and EI 201 exchange additionalinformation to initiate a communications session. The EI 201 and IMD 101connect, and the EI 201 is allowed to access the information gathered bythe IMD 101, such as intra-cardiac electrograms, pressure data, acousticdata, Sv02 data, and status information relating to the operation of IMD101. At this point in the process, the IMD 101 is fully awake.

FIG. 3B illustrates an example of initialization operations/blocks of aBLE peripheral application while in a partially awake state. The BLEperipheral application operates in a partially awake state until fullpower is required and is shown from a firmware perspective thatinteracts with the Bluetooth Low Energy system on a chip (SoC).

At 365, the wakeup timer expires and activates a partially wake (lowpower) BLE application. For example, in either application the IMD 101may wake up from a predetermined sleep interval. This interval may occurin between connection/advertising events. These connection/advertisingevents may be controlled by the timing control circuitry 179 as shown inthe block diagram in FIG. 2. The timing control circuitry 179 mayinclude a sleep clock. When the wakeup timer expires at the end of thesleep interval, the timing control circuitry 179 may process the currentconnection/advertising event and establish a new sleep interval usingthe sleep clock. At this point in the process, the IMD 101 is partiallyawake.

At 370, the processor startup routine is implemented similar to theroutine described in connection with the operations at 310. At 375, theRF circuit is initialized similar to the routine described in connectionwith the operations at 315.

The low power BLE application skips the steps from 325 through 340 asshown in the BLE peripheral application in a fully awake state. The lowpower BLE application does not initialize the memory block, the externalinstrument, the OS service, or the BLE protocol stack during thisportion of the process. This change in process shortens the timenecessary for the processor and hardware blocks to be active during eachadvertising opportunity, conserving energy.

At 380, the BLE peripheral application sends one or more advertisingnotices. At 385, the BLE peripheral application determines whether aconnection request was received. If no connection request is received,the process ends and the IMD goes back to sleep as illustrated at 395.Alternatively, if a connection request is received, the process proceedsto 390. At 390, the BLE peripheral application analyzes the connectionrequest and initiates a communications session if appropriate. At thispoint in the process, the IMD 101 is in the fully awake state.

FIG. 4 illustrates an example of an application switching sequencebetween a Low Power (partially awake) Advertising Application and a(fully awake) BLE peripheral Firmware Application. The IMD 101 transmitsadvertising notices 410 at advertising interval 412 during differentadvertising periods while in the partially awake state. The EI 201transmits a scan request 415 to request a connection to the IMD 101.Once the scan request 415 is received by the IMD 101, a scan response420 may be sent to the EI 201. If the scan response 420 indicates thatthe EI 201 is approved for a connection 440 to the IMD 101 andsubsequent communication 445, a switching operation 425 is initiated andthe partially awake advertising application 405 switches to the fullyawake advertising 430 when a connection request 435 is received. Thepartially awake advertising application 405 hands the process over tothe fully awake advertising application 430. The scan request 415 may beprocessed by analyzing identifying features of the EI 201.

When the fully awake advertising application 430 takes control, thememory block 194 is initialized (action/task 325 in FIG. 3A) in thefully awake advertising application. For example, program instructionsand/or parameters may be loaded into RAM, registers or other memorylocations. Various indices into the memory are initialized. In addition,an external instrument is initialized (action/task 330). In addition,the operating system services are initialized (action/task 335) and theBLE protocol stack 220 is initialized (action/task 340). Thereafter, acommunications session is established.

FIG. 5 is a state machine diagram illustrating states of a communicationcircuitry of an IMD 101, configured in accordance with an embodimentherein. Initially, the communication circuitry begins in a sleep state510. The communication circuitry remains in the sleep state until awakeup timer expires. Once the wakeup timer expires, the communicationcircuitry transitions from the sleep state to a partially awake state520, which also may be referred to as a low power advertising state.During the partially awake state, the communication circuitry isconfigured to transmit advertising notices over one or more channelsaccording to a wireless communications protocol and scan the one or morechannels for a connection request from an external device.

If a connection request is received from an external device, theconnection circuitry may be configured to transition to a fully awakestate 530. The fully awake state may also be considered a full poweradvertising state. During the fully awake state, the communicationcircuitry is configured to execute tasks and actions associated with acommunications protocol startup (CPS) instruction set that includes anadvertisement scanning related (ASR) instruction subset and a non-ASRinstruction subset. After completing the required handling duties, thecommunication circuitry may return to the sleep state until the nextwakeup timer expires.

If, however, a connection request is not received, the communicationcircuitry may return to sleep state, without performing actions or tasksassociated with the non-ASR instruction subset of the CPA instructionset.

Further, when the communication circuitry executes the CPA instructionset while in the fully awake state, utilizes a first amount of power.When executing the ASR instruction subset while in the partially awakestate, the communication circuitry utilizes a second amount of powerthat is less than the first amount of power. The complete CPSinstruction set includes more task and actions that take a longer periodof time and more power to implement versus the limited set of task andactions of the ASR instruction subset.

Additionally or alternatively, the communication circuitry may includehardware or firmware, in which case the ASR instruction subset mayinclude at least two of the following: i) expiration of a wake-up timer,ii) processor startup, iii) initialization of a transmit circuit, iv)transmission of advertising data packets, v) scanning one or morechannels for a connection request from an external device, or vi)validating or denying an incoming connection request. The ASRinstruction subset may not include non-ASR instruction subset.

Moreover, the communication circuitry may include hardware or firmware,and the non-ASR instruction subset may include at least two of thefollowing: i) initialization of a random-access memory (RAM)segment/block, ii) initialization of an external instrument component,iii) initialization of an operating system service, or iv)initialization of a communications protocol stack.

CLOSING

It should be clearly understood that the various arrangements andprocesses broadly described and illustrated with respect to the Figures,and/or one or more individual components or elements of sucharrangements and/or one or more process operations associated of suchprocesses, can be employed independently from or together with one ormore other components, elements and/or process operations described andillustrated herein. Accordingly, while various arrangements andprocesses are broadly contemplated, described and illustrated herein, itshould be understood that they are provided merely in illustrative andnon-restrictive fashion, and furthermore can be regarded as but mereexamples of possible working environments in which one or morearrangements or processes may function or operate.

As will be appreciated by one skilled in the art, various aspects may beembodied as a system, method or computer (device) program product.Accordingly, aspects may take the form of an entirely hardwareembodiment or an embodiment including hardware and software that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects may take the form of a computer (device) programproduct embodied in one or more computer (device) readable storagemedium(s) having computer (device) readable program code embodiedthereon.

Any combination of one or more non-signal computer (device) readablemedium(s) may be utilized. The non-signal medium may be a storagemedium. A storage medium may be, for example, an electronic, magnetic,optical, electromagnetic, infrared, or semiconductor system, apparatus,or device, or any suitable combination of the foregoing. More specificexamples of a storage medium would include the following: a portablecomputer diskette, a hard disk, a random access memory (RAM), a dynamicrandom access memory (DRAM), a read-only memory (ROM), an erasableprogrammable read-only memory (EPROM or Flash memory), a portablecompact disc read-only memory (CD-ROM), an optical storage device, amagnetic storage device, or any suitable combination of the foregoing.

Program code for carrying out operations may be written in anycombination of one or more programming languages. The program code mayexecute entirely on a single device, partly on a single device, as astand-alone software package, partly on single device and partly onanother device, or entirely on the other device. In some cases, thedevices may be connected through any type of network, including a localarea network (LAN) or a wide area network (WAN), or the connection maybe made through other devices (for example, through the Internet usingan Internet Service Provider) or through a hard wire connection, such asover a USB connection. For example, a server having a first processor, anetwork interface, and a storage device for storing code may store theprogram code for carrying out the operations and provide this codethrough its network interface via a network to a second device having asecond processor for execution of the code on the second device.

Aspects are described herein with reference to the figures, whichillustrate example methods, devices and program products according tovarious example embodiments. The program instructions may be provided toa processor of a general-purpose computer, special purpose computer, orother programmable data processing device or information handling deviceto produce a machine, such that the instructions, which execute via aprocessor of the device implement the functions/acts specified. Theprogram instructions may also be stored in a device readable medium thatcan direct a device to function in a particular manner, such that theinstructions stored in the device readable medium produce an article ofmanufacture including instructions which implement the function/actspecified. The program instructions may also be loaded onto a device tocause a series of operational steps to be performed on the device toproduce a device implemented process such that the instructions whichexecute on the device provide processes for implementing thefunctions/acts specified.

The units/modules/applications herein may include any processor-based ormicroprocessor-based system including systems using microcontrollers,reduced instruction set computers (RISC), application specificintegrated circuits (ASICs), field-programmable gate arrays (FPGAs),logic circuits, and any other circuit or processor capable of executingthe functions described herein. Additionally, or alternatively, themodules/controllers herein may represent circuit modules that may beimplemented as hardware with associated instructions (for example,software stored on a tangible and non-transitory computer readablestorage medium, such as a computer hard drive, ROM, RAM, or the like)that perform the operations described herein. The above examples areexemplary only, and are thus not intended to limit in any way thedefinition and/or meaning of the term “controller.” Theunits/modules/applications herein may execute a set of instructions thatare stored in one or more storage elements, in order to process data.The storage elements may also store data or other information as desiredor needed. The storage element may be in the form of an informationsource or a physical memory element within the modules/controllersherein. The set of instructions may include various commands thatinstruct the modules/applications herein to perform specific operationssuch as the methods and processes of the various embodiments of thesubject matter described herein. The set of instructions may be in theform of a software program. The software may be in various forms such assystem software or application software. Further, the software may be inthe form of a collection of separate programs or modules, a programmodule within a larger program or a portion of a program module. Thesoftware also may include modular programming in the form ofobject-oriented programming. The processing of input data by theprocessing machine may be in response to user commands, or in responseto results of previous processing, or in response to a request made byanother processing machine.

It is to be understood that the subject matter described herein is notlimited in its application to the details of construction and thearrangement of components set forth in the description herein orillustrated in the drawings hereof. The subject matter described hereinis capable of other embodiments and of being practiced or of beingcarried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. In addition, many modifications may be made to adapt aparticular situation or material to the teachings herein withoutdeparting from its scope. While the dimensions, types of materials andcoatings described herein are intended to define various parameters,they are by no means limiting and are illustrative in nature. Many otherembodiments will be apparent to those of skill in the art upon reviewingthe above description. The scope of the embodiments should, therefore,be determined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled. In the appendedclaims, the terms “including” and “in which” are used as theplain-English equivalents of the respective terms “comprising” and“wherein.” Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects or order ofexecution on their acts.

What is claimed is:
 1. An implantable medical device (IMD), comprising:sensing circuitry configured to collect biological signals; memoryconfigured to store program instructions; a processor configured toimplement the program instructions to at least one of analyze thebiological signals, manage storage of the biological signals or delivera therapy; communication circuitry configured to wirelessly communicatewith at least one other implantable or external device, thecommunication circuitry configured to transition between a sleep state,a partial awake state and a fully awake state; when in the fully awakestate, the communication circuitry configured to execute tasks andactions associated with a communications protocol startup (CPS)instruction set that includes an advertisement scanning related (ASR)instruction subset and a non-ASR instruction subset; when in thepartially awake state, the communication circuitry configured toexecute, as the ASR instruction subset: transmit advertising noticesover one or more channels according to a wireless communicationsprotocol; scan the one or more channels for a connection request from anexternal device; and when a connection request is not received, returnto the sleep state, without performing actions or tasks associated withthe non-ASR instruction subset of the CPS instruction set.
 2. The IMD ofclaim 1, wherein the communication circuitry configured to: transitionfrom the sleep state to the partial awake state in connection withexpiration of a timer; transition from the partial awake state to thefully awake state when a valid connection request is received; andtransition from the partial awake state to the sleep state when thevalid connection request is not received.
 3. The IMD of claim 1, whereinthe communication circuitry, when executing the CPS instruction setwhile in the fully awake state, utilizes a first amount of power andwherein the communication circuitry, when executing the ASR instructionsubset while in the partially awake state, utilizes a second amount ofpower that is less than the first amount of power.
 4. The IMD of claim1, wherein the CPS instruction set includes additional task and actionsthat take a longer period of time and utilize more power to implement ascompared to a period of time and power associated with implementing thetask and actions of the ASR instruction subset.
 5. The IMD of claim 1,wherein the communication circuitry includes at least one of hardware orfirmware, and wherein the ASR instruction subset includes at least twoof the following: i) expiration of a wake-up timer, ii) processorstartup, iii) initialization of a transmit circuit, iv) transmission ofadvertising data packets, v) scanning one or more channels for aconnection request from an external device, or vi) validating or denyingan incoming connection request, wherein the ASR instruction subset doesnot include non-ASR instruction subset.
 6. The IMD of claim 1, whereinthe communication circuitry includes at least one of hardware orfirmware, and wherein the non-ASR instruction subset includes at leasttwo of the following: i) initialization of a random-access memory (RAM)segment/block, ii) initialization of an external instrument component,iii) initialization of an operating system service, or iv)initialization of a communications protocol stack, wherein the non-ASRinstruction subset does not include ASR instruction subset.
 7. The IMDof claim 1, wherein the communications circuitry, when in the partiallyawake state, does not perform at least two of the following: i)initialization of a random-access memory (RAM) segment/block, ii)initialization of an external instrument component, iii) initializationof an operating system service, or iv) initialization of acommunications protocol stack.
 8. The IMD of claim 1, wherein the IMDrepresents at least one of a neurostimulator device, implantableleadless monitoring device, implantable leadless therapy device, bodygenerated analyze test device, pacemaker, cardioverter, cardiac rhythmmanagement device, or defibrillator.
 9. A computer implemented method,comprising: under control of one or more processors of a medical device,where the one or more processors are configured with specific executableinstructions, collecting biological signals; implementing programinstructions to at least one of analyze the biological signals, managestorage of the biological signals or deliver a therapy; communicatingwirelessly with at least one other implantable or external device;executing tasks and actions associated with a communications protocolstartup (CPS) instruction set that includes an advertisement scanningrelated (ASR) instruction subset and a non-ASR instruction subset whenin the fully awake state; when in a partially awake state, executing, asthe ASR instruction subset: transmitting advertising notices over one ormore channels according to a wireless communications protocol; scanningthe one or more channels for a connection request from an externaldevice; and returning to a sleep state, without performing actions ortasks associated with the non-ASR instruction subset of the CPSinstruction set when a connection request is not received.
 10. Themethod of claim 9, further comprising: transitioning from the sleepstate to the partial awake state in connection with expiration of atimer; transitioning from the partial awake state to a fully awake statewhen a valid connection request is received; and transitioning from thepartial awake state to the sleep state when the valid connection requestis not received.
 11. The method of claim 9, the method furthercomprising utilizing a first amount of power when executing the CPSinstruction set while in the fully awake state and utilizing a secondamount of power when executing the ASR instruction subset while in thepartially awake state, the second amount of power being less than thefirst amount of power.
 12. The method of claim 9, wherein the CPSinstruction set includes additional task and actions that take a longerperiod of time and utilize more power to implement as compared to aperiod of time and power associated with implementing the task andactions of the ASR instruction subset.
 13. The method of claim 9,wherein the ASR instruction subset further comprises at least two of thefollowing: i) expiration of a wake-up timer, ii) processor startup, iii)initialization of a transmit circuit, iv) transmission of advertisingdata packets, v) scanning one or more channels for a connection requestfrom an external device, or vi) validating or denying an incomingconnection request, wherein the ASR instruction subset does not includenon-ASR instruction subset.
 14. The method of claim 9, wherein thenon-ASR instruction subset further comprises at least two of thefollowing: i) initialization of a random-access memory (RAM)segment/block, ii) initialization of an external instrument component,iii) initialization of an operating system service, or iv)initialization of a communications protocol stack, wherein the non-ASRinstruction subset does not include ASR instruction subset.
 15. Themethod of claim 9, wherein, when in the partially awake state, themethod does not perform at least two of the following: i) initializationof a random-access memory (RAM) segment/block, ii) initialization of anexternal instrument component, iii) initialization of an operatingsystem service, or iv) initialization of a communications protocolstack.
 16. A computer program product comprising a non-signal computerreadable storage medium comprising computer executable code to: collectbiological signals; at least one of analyze the biological signals,manage storage of the biological signals or deliver a therapy;communicate wirelessly with at least one other implantable or externaldevice; execute tasks and actions associated with a communicationsprotocol startup (CPS) instruction set that includes an advertisementscanning related (ASR) instruction subset and a non-ASR instructionsubset when in the fully awake state; when in a partially awake state,execute, as the ASR instruction subset: transmit advertising noticesover one or more channels according to a wireless communicationsprotocol; scan the one or more channels for a connection request from anexternal device; and return to a sleep state, without performing actionsor tasks associated with the non-ASR instruction subset of the CPSinstruction set when a connection request is not received.
 17. Thecomputer program product of claim 16, further comprising computerexecutable code to: transition from the sleep state to the partial awakestate in connection with expiration of a timer; transition from thepartial awake state to a fully awake state when a valid connectionrequest is received; and transition from the partial awake state to thesleep state when the valid connection request is not received.
 18. Thecomputer program product of claim 16, further comprising computerexecutable code to utilize a first amount of power when executing theCPS instruction set while in the fully awake state and utilize a secondamount of power when executing the ASR instruction subset while in thepartially awake state, the second amount of power being less than thefirst amount of power.
 19. The computer program product of claim 16,wherein the CPS instruction set includes additional task and actionsthat take a longer period of time and utilize more power to implement ascompared to a period of time and power associated with implementing thetask and actions of the ASR instruction subset.
 20. The computer programproduct of claim 16, wherein the ASR instruction subset furthercomprises at least two of the following: i) expiration of a wake-uptimer, ii) processor startup, iii) initialization of a transmit circuit,iv) transmission of advertising data packets, v) scanning one or morechannels for a connection request from an external device, or vi)validating or denying an incoming connection request, wherein the ASRinstruction subset does not include non-ASR instruction subset.